NCT03397654|CompletedPhase 1/2ResultsDMC
Study of Pembrolizumab Following TACE in Primary Liver Carcinoma
PETAL
A Phase Ib Study of Pembrolizumab Following Trans-Arterial Chemoembolization in Primary Liver Carcinoma
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Sponsor study identifier
interventional
26
1 country
1
Study Start
January 28, 2018
Actual (reported)Primary Completion
February 1, 2023
Actual (reported)Study Completion
March 23, 2023
Actual (reported)Open label, single arm, multi-centre study of pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the safety and tolerability of pembrolizumab following TACE. The secondary objective is to evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival rates as measured by modified response evaluation criteria in solid tumours (mRECIST) criteria.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 23, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2017
Actual (reported)January 12, 2018
Actual (reported)January 28, 2018
Actual (reported)February 1, 2023
Actual (reported)March 23, 2023
Actual (reported)February 3, 2025
Actual (reported)Incidence of Treatment-emergent Adverse Events (Safety and Tolerability)
The safety and tolerability of pembrolizumab will be assessed by recording the incidence of adverse events (AEs) using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4).
from the first pembrolizumab administration to up to 130 days after the last dose, 1.5 years
Progression-free Survival Rate (PFS; Efficacy) at 12 Weeks
12 weeks
Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year
Pembrolizumab solution
Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
Imperial College Healthcare NHS Trust
London, United Kingdom
Fessas P, Scheiner B, D'Alessio A, M Fulgenzi CA, Korolewicz J, Ward C, Tait P, Thomas R, Cortellini A, Sharma R, Pinato DJ. PETAL protocol: a phase Ib study of pembrolizumab after transarterial chemoembolization in hepatocellular carcinoma. Future Oncol. 2023 Mar;19(7):499-507. doi: 10.2217/fon-2022-0916. Epub 2023 Apr 25.
Limitations include, limited sample size, lack of control arm and the Impact of Coronavirus disease pandemic, which made recruitment and retention of participants to the investigator-led clinical trial difficult, leading to reduction in the number of sample available for translational analysis.
26 participants (actual enrollment reported by the registry).
First Submitted
December 1, 2017
First Posted
January 12, 2018
Study Start
January 28, 2018
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2023
Actual (reported)Study Completion
March 23, 2023
Actual (reported)Last Updated
March 6, 2025
Results First Posted
February 3, 2025
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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